GDUFA Research Outcomes
Ophthalmic-Otic Products
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Asymmetric Flow Field Flow Fractionation for the Characterization of Globule Size Distribution in Complex Formulations: A Cyclosporine Ophthalmic Emulsion Case
Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Krishnaiah, Yellela; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions
Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance
Hu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Kozak, Darby; Shen, Meiyu; Weng, Yuting; Zhao, Liang; Lionberger, Robert
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Computational Modeling of Drug Transport across the In Vitro Cornea
Pak, Joseph; Chen, Zhijian; Sun, Kay; Przekwas, Andrzej; Walenga, Ross; Fan, Jianghong
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Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Products
Zhu, Dongkai
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Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants
Zhang, Feng
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Thinking Outside the Box: Adaptive Perfusion Method to Study Drug Release from Emulsions
Xu, Xiaoming
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Regulatory Perspective on MMF Applications for OIDPs, Ophthalmic Drug Products, and Drug Products Applied on the Skin
Walenga, Ross
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Bioequivalence Assessment for Complex Ophthalmic Products
Urtti, Arto
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GDUFA Research Update on Mechanistic Modeling Approaches for Generic Ophthalmic, Nasal, Implant and Injectable Drug Products
Tan, Mingliang